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Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

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ClinicalTrials.gov Identifier: NCT00213863
Recruitment Status : Unknown
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.

Condition or disease Intervention/treatment Phase
Vocal Cord Paralysis Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
Study Start Date : December 2010
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis


Intervention Details:
  • Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
    The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.


Primary Outcome Measures :
  1. Nasofibroscopy [ Time Frame: 8 days and 3 months after surgery ]
  2. Voice control and recording [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial ]
  3. All types of complication [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females greater than 18 years old

Exclusion Criteria:

  • Age less than 18 years
  • Pregnant women
  • Local carcinoma excluding radiotherapeutic or surgical control
  • Bad general condition
  • Contraindication to general anesthesia
  • Non-controlled diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213863


Contacts
Contact: Christian Debry, MD christian.debry@chru-strasbourg.fr

Locations
France
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre Recruiting
Strasbourg, France
Contact: Christian Debry, MD    33.3.88.12.76.45    christian.debry@chru-strasbourg.fr   
Principal Investigator: Christian DEBRY, MD         
Sub-Investigator: Philippe SCHULTZ, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Christian Debry, MD Hopitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00213863     History of Changes
Other Study ID Numbers: 3097
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by University Hospital, Strasbourg, France:
porous titanium implants
thyroplasty
vocal cord paralysis
male or female more than 18 years old

Additional relevant MeSH terms:
Paralysis
Vocal Cord Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases